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RECTOSACROUTEROPEXY vs. WELLS (RSUP)

A

Azerbaijan Medical University

Status

Active, not recruiting

Conditions

Pelvic Organ Prolapse (POP)
Rectal Prolapse

Treatments

Procedure: Wells rectopexy
Procedure: Modified rectosacrouteropexy

Study type

Interventional

Funder types

Other

Identifiers

NCT07673406
AMU-2026-STUDY-01
29/11/2019 Protocol N10 (Registry Identifier)

Details and patient eligibility

About

The goal of this clinical trial was to compare two surgical techniques in female patients with full-thickness rectal prolapse. The main questions it aimed to answer were:

  1. Does modified rectosacrouteropexy with pelvic peritonization improve postoperative anatomical outcomes compared with conventional Wells rectopexy?
  2. Does modified rectosacrouteropexy with pelvic peritonization improve postoperative functional outcomes compared with conventional Wells rectopexy?

Researchers compared modified rectosacrouteropexy with pelvic peritonization with conventional Wells rectopexy to assess postoperative recurrence, complications, anorectal manometry, defecography findings, and pelvic floor symptom scores. Participants underwent one of the assigned surgical procedures and were followed after surgery with clinical assessment and pelvic floor function testing.

Full description

This is a prospective randomized comparative study conducted at Azerbaijan Medical University. Female patients with full-thickness rectal prolapse are assigned to modified rectosacrouteropexy with pelvic peritonization or conventional Wells rectopexy. Participants are followed for postoperative anatomical and functional outcomes, including recurrence, complications, anorectal manometry findings, defecography findings, and pelvic floor symptom scores.

Enrollment

36 patients

Sex

Female

Ages

47 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients with full-thickness rectal prolapse Patients scheduled for surgical treatment with modified rectosacrouteropexy with pelvic peritonization Ability to complete postoperative follow-up assessments

Exclusion criteria

  • Male patients Patients without full-thickness rectal prolapse Contraindication to surgery or anesthesia Severe uncontrolled medical condition that could interfere with participation or follow-up

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Arm Title: Modified rectosacrouteropexy
Experimental group
Description:
Participants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse.
Treatment:
Procedure: Modified rectosacrouteropexy
Arm Title: Wells rectopexy
Active Comparator group
Description:
Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse
Treatment:
Procedure: Wells rectopexy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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